Medical Device Single Audit Program (MDSAP) Fundamentals

Course Description

The Medical Device Single Audit Program (MDSAP) is an international initiative to implement a program through which a single audit of a medical device manufacturer that will be accepted by multiple regulators to address QMS/GMP requirements. Participating regulatory authorities include Australia, Brazil, Canada, Japan and the USA.

This 1-day course is relevant for any size organization selling medical devices into the participating regions. It will help you to determine if your own Quality Management System processes are consistent with the requirements of the MDSAP audit model and assist in preparing you to host an MDSAP audit.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 Quality Management System.

Individuals responsible for Quality Assurance or Regulatory Affairs.

Senior Management

Quality Managers, Members of the Quality Team and/or Internal Audit Team

Learning Objectives

Understand the fundamentals, structure and scope of the MDSAP program.

MDSAP audit processes and their interrelationships.

MDSAP and organizational regulatory compliance.

MDSAP reporting and nonconformity grading.

Differentiate between MDSAP audits and other types of QMS audits.

Review the different MDSAP documents.

Review the MDSAP audit sequence.

Understand the 7 MDSAP processes and what auditors will be looking for when addressing each.

Prerequisites

None. This is an introductory course. (Previous experience working within an ISO 13485 quality management system and/or a medical device quality environment is helpful, but not required.)

Course Details

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

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ISO 9001:2015 Management Overview

Course Description

This flexible 1/2 Day (3.5 hour) course provides top management with a high-level overview of the ISO 9001:2015 standard, as well as the specific roles and responsibilities that are placed upon the organization’s leadership.

Participants will review the standard’s requirements, discuss key concepts relating to management activities, and discuss the ways in which an ISO 9001:2015 quality management system is aligned and integrated with the organization’s strategic goals and objectives.

Who Should Take It

Senior and executive managers who need a general understanding of their leadership role in an ISO 9001:2015 quality management system. This course is ideal for those who do not need a detailed understanding of the specific requirements, but who will be involved in high-level, strategic decision making and leadership roles.

Learning Objectives

Through presentation, discussion and several exercises, participants will:

Understand the structure of the ISO 9001:2015 standard at how it relates to the planning, production/service, and improvement activities of an organization.

Receive a general overview of the standard’s requirements.

Understand the “Process Approach” to quality and business management.

Understand the concept of “Risk-Based Thinking” and how to adopt a risk-based approach.

Understand the practical implication of the requirements around “leadership”, and the role of management in developing, leading and supporting quality management activities.

Gain an appreciation for the value that an effectively implemented ISO 9001:2015 QMS can bring to an organization.

Prerequisities

None. This is an introductory course for senior and executive management.

Course Details

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Understanding & Implementing Integrated ISO 9001, 14001 & 45001

2 days of training that deliver a solid understanding of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 requirements, as well as practical guidance on tools and approaches to implement an Integrated Management System meeting the requirements of all 3 standards.

A combination of presentation, discussion and immersive, hands-on exercises are used to explore:

Participants will also review key concepts (risk-based thinking, documented information, leadership, life-cycle perspective, consultation and participation of workers, etc.) and understand approaches and techniques for implementing these requirements and concepts in an integrated fashion.

See below for a full list of public course dates.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an integrated ISO 9001, ISO 14001 and ISO 45001 Management System. This includes, but is not limited to:

Those responsible for transitioning their organization’s system to meet the new requirements.

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

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Understanding & Implementing ISO 45001:2018

This 2-day course delivers an in-depth review of the ISO 45001:2018 requirements for occupational health and safety management systems.

Intended for members of the organization’s implementation team, this course teaches the standard’s requirements through discussion and immersive, hands-on exercises, and will review approaches and techniques for implementing these requirements within an organization.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 45001 OHSMS. This includes, but is not limited to:

Those responsible for transitioning their organization’s OHSMS to meet the new requirements.

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

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This 3-day course provides instruction on the specific requirements of an ISO 17025:2017 quality management system, the steps to effectively implement these requirements within an organization, and the practical skills and knowledge required to conduct audits in accordance with the ISO 9000 series of standards:

ISO 19011:2011 – “Guidelines for Auditing Management Systems”, and

“Guidance on the Concept and Use of the Process Approach for Management Systems”.

Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will learn the necessary elements to perform a quality audit.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 17025:2017 QMS. This includes, but is not limited to:

Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 17025:2017 requirements.

Senior Management

ISO Coordinators, Quality Managers & Management Representatives

Members of the Quality Team and/or Internal Audit Team

ISO 17025 Auditors, Quality Professionals and Consultants

Learning Objectives

Become familiar with the standard’s requirements (review of each section and its requirements).

Understand the timeline for transition (from ISO 17025:2005) and how it will affect your quality program (documentation, training, accreditation, etc.).

Appreciate the different factors that should be considered when implementing, or working within, an ISO 17025:2017 Quality Management System.

Identify the general approach to implementing the requirements of ISO 17025:2017.

Learn how to use the Gap Analysis as a tool to create an action plan for implementation.

Appreciate the roles and responsibilities of the Auditor.

Understand the basic skills and principles of auditing.

Apply the concepts and guidelines detailed in ISO 19011:2011 when performing an audit.

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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This introductory 2-day course provides a broad understanding of the requirements of ISO 17025:2017 – General requirements for the competence of testing and calibration laboratories. Through immersive, hands-on exercises and discussion, participants will review the standard’s requirements in detail and review approaches and techniques for implementing its requirements.

See below for a full list of public course dates.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 17025:2017 QMS. This includes, but is not limited to:

Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 17025:2017 requirements.

Senior Management

ISO Coordinators, Quality Managers & Management Representatives

Members of the Quality Team and/or Internal Audit Team

ISO 17025 Auditors, Quality Professionals and Consultants

Learning Objectives

Become familiar with the standard’s requirements (review of each section and its requirements).

Understand the timeline for transition (from ISO 17025:2005) and how it will affect your quality program (documentation, training, accreditation, etc.).

Appreciate the different factors that should be considered when implementing, or working within, an ISO 17025:2017 Quality Management System.

Identify the general approach to implementing the requirements of ISO 17025:2017.

Learn how to use the Gap Analysis as a tool to create an action plan for implementation.

Build confidence of QMS team members as they prepare to implement, or work within, an ISO 17025:2017 quality management system.

Prerequisites

None. This is an introductory course. (Previous knowledge of, or experience with, ISO 17025:2005 is beneficial but not required.)

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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👥Public Training

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Note: Course registration fees are invoiced 2 weeks in advance of course dates. Invoice may be submitted for payment by cheque or paid by credit card. Course fees are not required to be paid in advance of course dates.

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This 2-day course delivers a thorough understanding of the AS9100:2016 (Rev. D) requirements for aerospace quality management systems, along with a review of key concepts and techniques for implementing the requirements within an organization.

Through a combination of presentation, discussion and hands-on exercises, participants will learn to apply the key concepts and principles of the standard to the existing processes within their organization.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an AS9100:2016 (Rev. D) quality management system. This includes, but is not limited to:

Those responsible for implementing their organization’s QMS.

Senior Management

Quality Coordinators, Quality Managers & Management Representatives

Members of the Quality Team and/or Internal Audit Team

AS9100 Auditors, Quality Professionals and Consultants

Learning Objectives

Understand Annex SL – the “Structured Layer” design of the new Standard (i.e. new numbering system for clauses that will be consistent across standards).

Become familiar with the new standard’s requirements (review of each section and its requirements).

Understand key concepts and how they are applied within a QMS (Context of the Organization, Risk-Based Thinking, Leadership, Ethical Behaviour, Counterfeit Parts Production, and more).

Identify the general approach to implementing the AS9100:2016 (Rev. D) requirements.

Learn how to use the Gap Analysis as a tool to create an action plan for implementation.

Build the confidence of QMS team members as you prepare your implementation project.

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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This 2-day course provides in-depth review of the changes from TS 16949:2009 to ISO 9001:2015 and IATF 16949:2016. Through class discussion and hands-on exercises, participants will gain the necessary knowledge to support their organization’s transition to ISO 9001:2015 and IATF 16949:2016.

Intended for key members of the organization’s transition team with existing experience with quality management systems, this course provides critical knowledge for leadership, management and team members who need to understand the new requirements of ISO 9001:2015 and IATF 16949:2016 as they prepare to transition the organization’s QMS.

Who Should Take It

Individuals with responsibility for the implementation management, operation, or maintenance of an IATF 16949:2016 QMS. This includes, but is not limited to:

Implementation team responsible for transitioning the organization’s QMS to IATF 16949:2016.

Course Details

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Learn the new requirements through hands-on exercises and class discussion, and review in detail the changes from the ISO 13485:2003 standard to this new ISO 13485:2016 edition. This course provides critical knowledge for leadership, management and team members who need to understand the new requirements of ISO 13485:2016 as they prepare to transition the organization’s QMS.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485 QMS. This includes, but is not limited to:

Those responsible for transitioning their organization’s QMS to meet the new requirements

Senior Management

ISO Coordinators & Quality Managers

Members of the Quality Team and/or Internal Audit Team

ISO 13485 Auditors, Quality Specialists and Consultants

Learning Objectives

Become familiar with the new standard’s requirements (review of each section and its requirements).

Recognize the changes relative to the previous ISO 13485:2003 standard.

Understand the timeline for transition and how it will affect your quality program (documentation, training, registration, etc.).

Identify the general approach to implementing the new requirements of ISO 13485:2016.

Build the confidence of quality team members as you prepare your transition project.

Course Details

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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An in-depth study of the ISO 14001:2015 standard for Environmental Management Systems.

Learn the requirements through hands-on exercises and class discussion, and review approaches to implementation. Critical knowledge for leadership, management and team members who need understand the requirements of ISO 14001:2015.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 14001 EMS. This includes, but is not limited to:

Those responsible for implementing an ISO 14001:2015 EMS or transitioning their organization’s EMS to meet the new requirements

Senior Management

ISO Coordinators, Environmental Managers & Management Representatives

Members of the Environmental Team and/or Internal Audit Team

ISO 14001 Auditors, Environmental Specialists and Consultants

Learning Objectives

Understand Annex SL – the “Structured Layer” design of the Standard (i.e. numbering system for clauses that will be consistent across standards).

Become familiar with the standard’s requirements (review of each section and its requirements).

Understand the timeline for transition from the previous edition and how it will affect your environmental program (documentation, training, registration, etc.).

Identify the general approach to implementing the requirements of ISO 14001:2015.

Understand the concept identifying risks associated with “Threats and Opportunities”.

Identify the requirements for “documented information” and how this will (and will not) require changes to your existing documentation.

Understand the practical implication of the requirements around “leadership”.

Understand the concept of using a “life cycle perspective” when identifying aspects and impacts.

Learn how to use the Gap Analysis as a tool to create an action plan for implementation.

Build the confidence of EMS team members as you prepare your implementation project.

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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👥Public Training

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Note: Course registration fees are invoiced 2 weeks in advance of course dates. Invoice may be submitted for payment by cheque or paid by credit card. Course fees are not required to be paid in advance of course dates.

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